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Chlorhexidine and nystatin in the treatment of oral candidosis - a pilot study

Phase 1
Conditions
oral candidosis
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Registration Number
EUCTR2016-005027-81-FI
Lead Sponsor
Maria Siponen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
40
Inclusion Criteria

Oral candidosis diagnosed with oral swab
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Age under 18, pregnancy or planning pregnancy, allergy to chlorhexidine, nystatin or additional ingredients of the study products, hereditary fructose-intolerance, fructose-intolerance, glucose-galactose absorption disorder, or saccarose-isomaltase deficiency, oral mucosal disease such as lichen planus or mucous membrane pemphigoid with severe symptoms, immunosuppressive condition such as untreated HIV-infection, on-going treatment for cancer, systemic immunosuppressive medication, desinfectant oral rinse or yeast infection medication used during the last four weeks.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To examine the use of chlorhexidine in the treatment of oral candidosis;Secondary Objective: To study the different diagnostic methods of oral candidosis and to study the salivary metabolites in oral candidosis;Primary end point(s): not/applicaple;Timepoint(s) of evaluation of this end point: not/applicaple
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): not/applicaple;Timepoint(s) of evaluation of this end point: not/applicaple
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